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Table 1 Characteristics of included studies (n = 2311)

From: Chinese herbal medicines in the treatment of ulcerative colitis: a review

Characteristic

n (%)

Type of study

 Randomized controlled trial (RCT)a

2164 (93.6)

 Othersb

147 (6.4)

Trial participating centre

 Single centre

2243 (97.1)

 Multicentre

68 (2.9)

Type of blinding

 Open label

2243 (97.1)

 Single

34 (1.5)

 Double

34 (1.5)

Sample size

 Median and IQR (inter-quartile range)

78 (60–100)

Number of assigned groups

 2

2228 (96.4)

 3

73 (3.2)

  > 3

10 (0.4)

Clinical phases of UC

 Activec

1645 (71.2)

 Remission

636 (27.5)

 Both

30 (1.3)

UC with CM pattern (zheng)

 Yes

895 (38.7)

 No

1416 (61.3)

CM pattern with a diagnosis criteria basis or referenced

 Yese

635 (70.9)

 Nof

260 (29.1)

Type of CHM interventions

 

 Chinese single herb(s)

20 (0.9)

 CHM formula(s)

2291 (99.1)

Type of CHM formulasg

 

 Fixed CHM formulas

1332 (58.1)

 Individualized CHM formulas

817 (35.4)

 Patent proprietary CHM formulas

191 (8.3)

Dosage formh

 

 Decoction

2015 (87.2)

 Granule

71 (3.1)

 Powder

71 (3.1)

 Capsule

61 (2.6)

 Enema

41 (1.8)

 Othersi

124 (5.4)

Administration route

 

 Oral

806 (34.9)

 External

951 (41.2)

 Both

554 (24.0)

Administration time of CHM intervention (weeks)

 

 Median and IQR (inter-quartile range)

6 (4–9)

Follow-up period (weeks)j

 

 Median and IQR (inter-quartile range)

26 (21–52)

Treatment group

 

 Only CHM intervention(s)

1418 (61.4)

 CHM combined with Western medicine(s)

893 (38.6)

Type of controls

 

 Active control

1268 (54.9)

 Add on control with baseline treatment

735 (31.8)

 Placebo control

34 (1.5)

 Blank or waitlist control

4 (0.2)

 Othersk

270 (11.7)

Outcomes including CM-related indicators

 

 Yes

524 (22.7)

Outcomes including safety assessment

 

 Yes

697 (30.2)

 No

1614 (69.8)

Adverse effects (AE) reportedl

 

 No AE was identified

467 (67.0)

 Specific AE was reportedm

230 (33.0)

  1. aIncluding both randomized and quasi-randomized controlled trials
  2. bIncluding non-randomized controlled trials, controlled observational studies, cohort study, cross-sectional study, and case–control studies
  3. c Including mild, moderate, and severe active UC
  4. d The percentage of this item was based on the number of records that included CM pattern diagnosis (n = 895). For example, 70.9% = 635/895
  5. e Reporting of how the CM pattern is diagnosed and what criteria are used for including and excluding participants, such as specific description or reference(s) where detailed explanation(s) can be found
  6. f Only provided the name(s) of CM pattern without any diagnosis criteria
  7. g Some trials included more than one type of formulas, such as both individualized formula and patent proprietary formula were included; these were counted in different columns. Thus, the total number of formula types was above 2,291. But the total number of articles that studied CHM formulas was 2,291, therefore, the percentage of each sub-item was based on 2,291
  8. h Some trials included more than one CHM interventions with different dosage forms; these were counted in different columns. Thus, the total number of dosage forms was above 2,311. We listed the top five in the Table, and categorized the remaining dosage forms into the column of “Others”
  9. i Including Pill (32), Plaster (28), Suppository (25), Tablet (23), Injection (9), Cataplasm (4), and Gelatin (3)
  10. j Among 2,311 studies, only 492 (21.3%) articles reported the follow-up arrangement
  11. kThe control group included other CHM prescription(s), such as common CHM formula, fixed CHM formula, or patent proprietary CHM formula, etc. Besides, different doses or dosage form of CHM formulas were also included as the control
  12. l The percentage of this item was based on the number of articles that included safety assessment (n = 697). For example, 70.8% = 635/897
  13. m The specific AEs were provided in Additional file 1: Appendix S3 with detailed symptoms and its reporting frequency
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Chinese Medicine

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